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Category Archives: Prescription medication

Agent 007 and the secret Japanese company Daiichi Sankyo must find and stop the true culprit of a series of attacks on visual and auditory regions of the brain in fibromyalgia patients.

Guess what I did today!

After only 5 hours sleep (I was up ‘til 3am with friends drinking vodka), I went to an appointment, stopped at the nursery to pick up some plants and soil, did some gardening, played with Kimba, finished the laundry and made some important phone-calls. Pretty cool, huh?

The appointment I went to was for another drug trial check-up. I bounced in, a little hung-over but full of beans. I’m feeling like the old me – could this be a second chance at my life?

The doctor and nurse practitioner looked on kinda stunned. (Remember, none of us know exactly what drug I’m taking.) I’m kinda stunned…on Sunday, I realised that I was happy – really happy – and I don’t know when I last felt happiness. I guess antidepressants just keep you on an even keel and you don’t realise that you’re not happy; you just know that you no longer feel so bad. I find myself singing to the radio where, before, I couldn’t handle the radio even being on.

Now, I may be the only person in the world feeling this kind of effect but I hope not. I would love all of you to start feeling this well. BUT, right now (3 weeks into the trial), I’m calling MIRACLE!

Like this:

007 heads to Malvern East to recover Good Health and Energy stolen by SPECTRE agent nicknamed Fibromyalgia in an international extortion scheme.

I have now been on the Daiichi Sankyo sanctioned medication for 7 days. It would be absolutely fantastic if my medication was the placebo because I’m feeling pretty damn good; and that would mean that my Fibromyalgia was gone.

Today I woke up, took Kimba (my puppy) out for some play, did a load of washing, hung it out in the sun; and folded some dry laundry. A pretty good morning! So, I doubt that I’m on the placebo.

It hasn’t all been smooth sailing, though. A couple of nights ago, I had to put some ointment in a place that we don’t talk about in good company. It’s a reoccurrence of an ‘accident’ that happened quite a while ago. The wonderful ointment for this lovely and embarrassing condition has the possible (and very probable for us) side effects of headaches and dizziness. Ta Da! Two minutes after application, stabbing pain in the left side of my head – not happy, Jan! The minimal amount of Panadol that I am permitted (in the research study) couldn’t touch the pain. I knew that if I could just get rid of the headache (I was sure the headache was from the ointment and not the new drugs), I’d be okay. The headache (and extreme light sensitivity – you know how it is) lasted 3 days.

007 willingly falls into an assassination ploy involving a naive Russian Japanese pharmaceutical company in order to retrieve a cure for Fibromyalgia that was stolen by SPECTRE.

I’ve been keeping an electronic diary for the research study. Each morning, it asks me what is the highest level of pain I have experienced over the past 24 hours. Yes, I hate that question…and now I get to answer it at least once a day.

By the time I started the diary, I had not had any pain meds (except Panadol) for 4 days. Bloody! Bloody! I had forgotten about the stiffness and inability to sleep so on Friday, after 3 hours sleep, I thought: well, I haven’t been in this kind of pain in a very long time (it’s funny how I forget how bad the pain actually was at its worse) but it’s not a 9 or 10 – I’m not in hospital so I answered:

On Saturday, the mind-blowing headaches in the bones above and below my eyes were back. Bummer! I had forgotten about those; but, I thought: well, I haven’t been in this kind of pain in a very long time but it’s not a 9 or 10 – I’m not in hospital so I answered:

On Sunday, the costochondritis returned. I lay on my couch all day under a heated blanket; but, I thought: well, I haven’t been in this kind of pain in a very long time but it’s not a 9 or 10 – I’m not in hospital so I answered:

On Monday, my stomach and lower back began spasming. Oh, here comes the irritable everything syndrome. I thought: well, I haven’t been in this kind of pain in a very long time but it’s not a 9 or 10 – I’m not in hospital so I answered:

On Tuesday, I had a funeral so I didn’t fill in anything all day – I was afraid to take my electronic diary with me because I couldn’t work out how to turn off the alarm.

On Wednesday and Thursday, my hands and feet felt (but didn’t look) swollen and full (I can’t think of any other word), so uncomfortably full so, I thought: well, I haven’t been in this kind of pain in a very long time but it’s not a 9 or 10 – I’m not in hospital so I answered:

Each day the pain had gotten worse but I had started too high on the scale. It was never the worst pain I have ever experienced but, each day should have been higher than the day before.

Maybe it’s time to consider a different way to ask the question? Maybe it should be, if yesterday was a 5, how much pain have you experienced in the last 24 hours? And then, is it more (or less) pain than yesterday?

No longer is Lyrica, Voltaren, Tramadol, Endone or anything stronger than Panadol living in my pill organiser. I have been weened off everything.

Today, I went for my second appointment at Emeritus Research. I had pretty much written-off my weekend, just in case I had side effects from whichever drug they put me on but (please press)

Today I was shown how to use my electronic diary…and that’s it. How disappointing: I have to wait ‘til next week before I start whichever regime I have been randomly chosen to undertake. I will be (randomly) assigned to one of 4 groups: Placebo, 300mg Lyrica, 15mg Mirogabalin or 30mg Miroglabin. There will be regular check-ups for the entire time.

I got to Emeritus Research at 11am. The place looks like any other office…with 3 assessment rooms at the back, filled with medical equipment. It seems a little disorganised and haphazard; but I’m looking forward to being involved.

I had a meeting with a nurse practitioner and a doctor. They took a very, very long history, asking questions about almost EVERYthing to do with my medical history (including a questionnaire called the MINI, which I must say is just plain stupid!). I was required to give a urine sample (to check if I am pregnant), some blood work and an EKG. The doctor did a relatively quick physical and, of course, checked all my pressure points. All in all, with a few technical issues, it took about 2 hours.

The first part of the study is 13 weeks long. I have to come off the Lyrica that I am already on. Then I will be (randomly) assigned to one of 4 groups: Placebo, 300mg Lyrica, 15mg Mirogabalin or 30mg Miroglabin. There will be regular check-ups for the entire time.

After the 13 week trial, there may be an opportunity to enter the 52 week Miroglabin trial.

Daiichi Sankyo, a Japanese drug company, is confident it’s struck gold with its’ new drug, Mirogabalin. Daiichi Sankyo believes it will be more potent, have fewer side-effects and be longer-acting than Lyrica. That’s could be a one-two punch combination for many of us who either didn’t derive benefit from the Lyrica or not enough benefit to stay on it.

A major fibromyalgia drug trial is underway in the U.S and Canada. (Want to be part of it? Contact Daiichi using this email – SM_DS5565_FM_Info@incresearch.com. Ninety-four study locations are present in the U.S. and Canada.).

Daiichi Sankyo believes mirogabalin is a significant upgrade on Lyrica. A 2014 study suggested that mirogabalin’s may be 17 times more potent than Lyrica. Both drugs bind to calcium channels that have been implicated in the production of neuropathic pain. Mirogabalin is believed to bind to a calcium channel subunit that has strictly analgesic properties. Lyrica, on the other hand, also binds to another subunit that has central nervous system effects – this is what may be responsible for its side effects.

A 1,000 person U.S./Canadian trial is assessing mirogabalin’s effectiveness in fibromyalgia. The trial makeup – putting the two drugs head to head – indicates Daiichi wants to topple the frontrunner and install mirogabalin as the preferred drug for FM.

Ages and ages ago (except it doesn’t feel that long ago – doesn’t time fly when you’re in a fibro fog!), I (with my doctor’s advice) weaned myself off Lyrica to see if we could find a better way to deal with this condition. If you followed the posts, you’ll remember that I ended up at Step 1 again and back on it…almost immediately.

Basically, it seemed, I was given the choice of being in pain (no Lyrica) or no brain (with Lyrica). I chose no pain.

I am beginning to question my choice…as my brain and everything in it quickly turns to mush.

To make matters worse (yes, they can get worse), antidepressants block the action of acetylcholine. What does acetylcholine do, you might ask? It is the primary neurotransmitter involved with memory and learning. And, how many of us take antidepressants? I know that I do. See what I mean by things getting worse?

Premier Biomedical, Inc. (OTCBB: “BIEI”) a bio-pharmaceutical company focused on developing and commercializing innovative immune system manipulation therapies for breast cancer, Alzheimer’s disease, multiple sclerosis (MS), traumatic brain injury (TBI), and others today announced that the United States Patent Office approved a patent on their proprietary medication “Feldetrex ™”, which is designed to relieve the symptoms of neuropathic pain and fibromyalgia.

The William Beaumont Army Medical Center Principal Investigator is drafting a protocol to conduct a double-blind, placebo-controlled comparison of this medication and the leading FDA-approved regimen for these concerns and will be submitting it for IRB approval in the near future.

President and CEO, William A. Hartman, stated, “We are very excited that the United States Patent Office granted our request for a patent on Feldetrex ™. We are very confident in our ability to perform well in the upcoming double-blind clinical study because of the favorable responses we have received to date from the limited number of patients that have taken the medication thus far. We are applying for FDA approval immediately and are also confident that our application will be approved, since Feldetrex ™ consists only of a skillful and proprietary combination of FDA-approved ingredients. The market for such a medication worldwide runs into many billions of dollars. We believe that our medication will also fare very well versus competition due to its projected lack of serious side effects. The market should see results very quickly as the double-blind study is tentatively scheduled to be concluded later this calendar year.”

However, it should be noted, Premier Biomedical’s own website states that “Our Feldetrex™ candidate drug will not compete with currently existing treatments of Fibromyalgia, but, rather, would be an add-on-drug to increase the effectiveness of treatment.”

More About Premier Biomedical Inc and Feldetrex:

Premier Biomedical Inc. (OTC: BIEI), a bio-pharmaceutical company focused on developing and commercializing innovative immune system manipulation therapies for a variety of medical conditions, recently announced that the U.S. Patent Office approved a patent on its proprietary medication Feldetrex™, which is designed to relieve the symptoms of neuropathic pain and fibromyalgia.

In the near future, the William Beaumont Army Medical Center Principal Investigator will draft a protocol for a double-blind, placebo-controlled comparison of Feldetrex™ and a leading FDA-approved regimen. The early-stage clinical trials should provide management and investors with key insights into the safety and efficacy of the treatment compared to options that are already available on the market.

Last night one of your commercials for Lyrica came on TV. In this ad a woman claimed her overactive nerves, caused by Fibromyalgia, gave her pain and kept her from doing the things she wanted to do in life. Obviously she went on to tout the praises of your drug, but I wasn’t listening. Instead, I was hung-up, obsessing, and ranting and raving over the use of one word, wanted. Fibromyalgia kept her from doing the things she wanted to do in life? Like rock climbing or going to an Eminem concert? Because this Fibromyalgia patient over here experienced a completely different reality. Not only did Fibromyalgia keep me from doing the things Iwanted to do, it also kept me from doing the things I had to do, like washing my hair and going to work. And I know a hell of a lot more patients sing my song than Miss Wanted To Do’s.

I have added this video as we don’t have ads for prescription drugs on TV (and I’m not sure about all other countries):

Needless to say, as a nine year veteran of Fibromyalgia, I found this phrasing offensive. In short, here’s my beef; You’re $opping up the dough off a disease that isn’t technically a disease, because nobody knows what causes it. So it wouldn’t hurt too much to throw us patients a bone, would it? Because we’re in a pickle and sure could use your help. Not only is Fibromyalgia the leading pain condition diagnosed in the USA, patient symptoms run the gamut, with a range of fluctuating severity. It affects everyone differently, and to make it even more convoluted, the treatments do, too. Please understand I am an educated consumer. In no way am I holding any pharmaceutical company responsible for sourcing the cause and cure of this mysterious ailment. And I’m well aware of how expensive the process of developing a drug, testing it, and bring it to market actually is. I’m even hip to the efforts your company invests in regarding Fibromyalgia awareness and cause advancement. But maybe it’s because of these reasons I’m actually pissed at you.

I know you pay a pretty premium for the advertising, but as of right now, Pfizer, you are the voice of our illness. Countless patients have lost their ability to function from Fibromyalgia, along with their jobs, families, friends and homes. Fibromyalgia is a devastating reality hotly debated in the crossroads of modern and psychiatric medicine, yet nobody can deny the number of patients is only growing larger. As the only other source of the word “Fibromyalgia” to many people in our society, other than ‘strange Aunt Sally who doesn’t like to leave her house’, you would do the aforementioned injustice a world of good if the chick on the Lyrica commercial said had. ‘Fibromyalgia kept me from doing the things I had to do in life.’ It would give millions of people some much-needed validation.

Thank you for your consideration,

Leah Tyler

I’m probably looking at this from a different point of view than most: I have been trying to encourage all of us, via this site, Facebook and Twitter, to become a voice for Fibromyalgia by sending emails, sharing posts or tweeting; and, then, on May 12th, lighting up their home with purple bulbs (this part is the only bit that may require some physical exertion). (Don’t know what I’m talking about? Check this out.) However, due to the very nature of our condition, it is so difficult to get many of us to actually do any of this…so, yes, it is sad that, despite how hard some of us try, Lyrica ads are the only voice for us!

John Quintner, MD, is a rheumatologist and pain medicine specialist in Australia who recently retired from clinical practice.He has published numerous articles on chronic pain in Pain Medicine, Clinical Journal of Pain, The Lancet and other medical journals.

Most fibromyalgia sufferers will at some stage be offered a prescription for one or more of the officially approved drugs – Lyrica, Cymbalta, and Savella.

Many will ask their doctors two important questions: How good are these drugs and what harm can they cause me?

Many would be surprised by the answers they get – if the doctor is willing and able to provide them.

The concepts of NNT/NNH

One way to assess the effectiveness of drugs for pain management is by looking at the Number Needed to Treat (NNT) value.

The NNT value for drugs used to treat specific painful conditions is derived from large clinical trials that record the number of patients who report 50% or more reduction in their pain, compared to results from a placebo. The lower the NNT, the better the drug.

For example, if 10 patients with a specific condition are prescribed a drug and only one of them reports relief of pain, the NNT value for that drug is 10. This means that the other 9 patients will find the drug to be ineffective.

Continuing on the same theme, the potential for drugs to cause harmful side effects is expressed by another value – the Number Needed to Harm (NNH).

The NNH values for the three fibromyalgia drugs gives us an indication of how many patients need to be treated before one of them will report a harmful side effect. The higher the NNH, the safer the drug is.

By the way, it is well known that people taking placebo drugs can report adverse events.

This means that only one out of 10 patients taking Lyrica (Preglabin) will have pain relief of 50% or more. Only one out of 6 taking Cymbalta (Duloxetine) will have relief of pain and only about one out of 8 taking Savella (Milnacipran).

NNH for Fibromyalgia Drugs

The overall values for side effects of each drug, when compared to placebo, and expressed as NNH are as follows: between 6 -18 for Cymbalta; between 7-14 for Savella 7-14; and around 6 for Lyrica.

This means for every 6 patients with fibromyalgia treated with Lyrica, one of them will report a harmful side effect. There is a wide range of NNH’s for both Cymbalta and Savella.

Some adverse effects are relatively minor and will not deter a person from taking an effective drug. Other adverse effects are more serious and can be a reason for discontinuing the drug.

In the case of Lyrica, randomized controlled trials have shown that doses of 600 mg daily produce drowsiness in 15-20% and dizziness in 27% to 46%.

Other side effects include dry mouth, weight gain, peripheral oedema (swelling). In another important review, it was found that treatment was discontinued due to adverse events in one out of 4 patients.

In summary, a minority of patients will report substantial benefit with Lyrica, and more will have moderate benefit. Many will have no or trivial benefit, or will discontinue the drug because of adverse events.

Is this the sort of information that patients would like to have given to them?

In my experience, the answer is a resounding YES. But as each person is a unique individual, it is impossible to accurately predict who will and who will not like a particular drug.

“Doctors are men who prescribe medicines of which they know little, to cure diseases of which they know less, in human beings of whom they know nothing.”

These oft-quoted words by the French philosopher Voltaire [1694-1778] still have a ring of truth about them. We now know much more about the drugs we prescribe, and about the various diseases we have uncovered and classified. But we still have much to learn about the responses of individual human beings.

Those who have been awarded a diagnosis of fibromyalgia find themselves in a “double bind.”

On the one hand, the very diagnosis can arouse disbelief at all levels of society and, on the other hand, the available drugs afford most of them little, if any, relief of pain.